Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
1. Claims 1-9 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
With respect to claims 1-9, the claims recite the step of “a prediction unit configured to predict presence/absence of a disease and a degree of the disease from the electrocardiogram data input from the single-lead electrocardiogram measurement unit based on a diagnostic algorithm previously constructed by being trained on a plurality of standard electrocardiogram datasets in which standard lead electrocardiograms measured for same electrical axes are matched to presence/absence of diseases and degrees of the diseases corresponding to the standard lead electrocardiograms”. However, the specification does not provide any working examples, guidance, or steps as to how this function is achieved. Rather, the specification only mentions the use of algorithm training. For example, how is this ECG data being used to determine any and all conditions/degree of conditions a patient could experience? Further, claim 9 recites “generate[ing] the asynchronous electrocardiogram data, measured from the single-lead electrocardiogram measurement unit, as numerical data through a specific formula”; however, it is unclear what the formula is or how it is being used to generate the asynchronous electrocardiogram data.
As noted in the MPEP, original claims may lack written description when the claims define the invention in functional language specifying a desired result but the specification does not sufficiently describe how the function is performed or the result is achieved. For software, this can occur when the algorithm or steps/procedure for performing the computer function are not explained at all or are not explained in sufficient detail (simply restating the function recited in the claim is not necessarily sufficient).
It is not enough that one skilled in the art could write a program to achieve the claimed function because the specification must explain how the inventor intends to achieve the claimed function to satisfy the written description requirement
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
2. Claims 5 and 9 rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
In regards to claim 5, it is unclear what is meant by an “electrocardiogram data generation unit configured to generate a plurality of pieces of standard lead electrocardiogram data that are not measured by the single-lead electrocardiogram measurement unit and, thus, are not matched to standard lead electrocardiograms based on a plurality of pieces of asynchronous electrocardiogram data measured by the single-lead electrocardiogram measurement unit”. For example, how is electrocardiogram data being generated if it is not measured by the claimed electrocardiogram leads? Clarification of the claim is needed. For examination purposes, the Examiner in interpreting this to mean that the ECG unit is taking in the asynchronous ECG data and then making determinations about the presence/absence of a disease from this data.
In regards to claim 9, the Applicant teaches “generate[ing] the asynchronous electrocardiogram data, measured from the single-lead electrocardiogram measurement unit, as numerical data through a specific formula”. However, it is unclear what the formula is or how it is being used. Clarification is needed.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
3. Claims 1-9 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The independent claims 1 recites “a system for predicting a health condition using a single-lead electrocardiogram device…configured to obtain electrocardiogram data by measuring electrocardiograms for at least two electrical axes at different times; and a prediction unit configured to predict presence/absence of a disease and a degree of the disease from the electrocardiogram data”. The limitation, as drafted, is a process that, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components. For example, looking at ECG data and then making a determination about a condition of a patient could simply be done by looking at the data on a printout or screen or could be accomplished mentally. If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components, then it falls within the “Mental Processes” grouping of abstract ideas. This judicial exception is not integrated into a practical application.
The components are recited at a high-level of generality such that it amounts no more than any structure that can take in ECG data and determine conditions from said data. Further, the use of electrodes and wearable devices in the claims, are merely insignificant extra-solution activity of data gathering. Accordingly, these additional elements do not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea. The claim is directed to an abstract idea.
The additional elements, such as the electrodes and the wearable device, while being mere structures for data gathering are also well-understood, routine, conventional activity that is widely prevalent or common use in the relevant industry. The use of electrodes and wearable devices to gather patient information are well known in the art as disclosed by the following references: US 20210173045 A1 and US 20170071483 A1. Well-understood, routine and conventional activity cannot be significantly more than the abstract idea itself. The claims are not patent eligible.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
4. Claim(s) 1--9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Viktorovich (US 20200352440 A1) in view of Hu (US 20210173045 A1).
In regards to claim 1, Viktorovich teaches a system for predicting a health condition using a single-lead electrocardiogram device (Abstract teaches using a single lead ECG to determine a condition of a user), the system comprising:
a single-lead electrocardiogram measurement unit provided with two electrodes (Par. 0010 teaches the use of multiple electrodes), and configured to obtain electrocardiogram data by measuring electrocardiograms for at least two electrical axes at different times (Par. 079 teaches taking in data from the ECG over an observation period. Par.0141 teaches this observation period can be 5 different ECG readings at different times during the day); and
a prediction unit configured to predict presence/absence of a disease and a degree of the disease from the electrocardiogram data input from the single-lead electrocardiogram measurement unit based on a diagnostic algorithm previously constructed by being trained on a plurality of standard electrocardiogram datasets in which standard lead electrocardiograms measured for same electrical axes are matched to presence/absence of diseases and degrees of the diseases corresponding to the standard lead electrocardiograms (Par. 0096 teaches taking in the ECG data and then using unit [8] to make a prediction of a patients condition/disease based on previous readings of the patient, i.e. training from past readings).
While Viktorovich teaches taking ECG data at different times of day, they do not explicitly teach using asynchronous data. However, in the same field of endeavor, Hu teaches a method for making health predictions based on ECG data (Abstract and Par. 0043) wherein data taken from a subject can be asynchronous (Par. 0256) in order to improve system efficiency.
Therefore, it would be obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have taken the teachings of Viktorovich and modified them by using asynchronously measured data, as taught and suggested by Hu, in order to improve system efficiency.
In regards to claim 2, the combined teachings of Viktorovich and Hu teach the system of claim 1, wherein the diagnostic algorithm is constructed to output and predict presence/absence of a disease and a degree of the disease corresponding to asynchronously measured standard lead electrocardiogram data by using the asynchronously measured standard lead electrocardiogram data as input (Par. 0096 of Viktorovich teaches taking in the ECG data and then using unit [8] to make a prediction of a patients condition/disease. Par. 0105 of Viktorovich teaches that the progression of the condition is also determined; i.e. the degree of the disease)
In regards to claim 3, the combined teachings of Viktorovich and Hu teach the system of claim 1, wherein the diagnostic algorithm is constructed to output and predict presence/absence of a disease and a degree of the disease corresponding to standard lead electrocardiogram data by using the standard lead electrocardiogram data, in which time series information has been deleted from synchronously measured standard lead electrocardiogram data, as input (The Examiner is interpreting this to mean that the data is just asynchronous, which is taught by Hu).
In regards to claim 4, the combined teachings of Viktorovich and Hu teach the system of claim 1, wherein the diagnostic algorithm is constructed to convert a plurality of pieces of asynchronous electrocardiogram data, measured and input at different times from the single-lead electrocardiogram measurement unit, into synchronous electrocardiogram data and predict presence/absence of a disease and a degree of the disease from the resulting synchronous electrocardiogram data (Par. 0256 of Hu teaches making synchronized data asynchronized and vice versa).
In regards to claim 5, the combined teachings of Viktorovich and Hu teach the system of claim 4, further comprising an electrocardiogram data generation unit configured to generate a plurality of pieces of standard lead electrocardiogram data that are not measured by the single-lead electrocardiogram measurement unit and, thus, are not matched to standard lead electrocardiograms based on a plurality of pieces of asynchronous electrocardiogram data measured by the single-lead electrocardiogram measurement unit; wherein the diagnostic algorithm outputs and predicts presence/absence of a disease and a degree of the disease by using the measured asynchronous electrocardiogram data and the generated standard lead electrocardiogram data as input or using the generated standard lead electrocardiogram data as input (Based on the Examiners best understanding of the claim in light of the specification, they are interpreting this claim to mean that the ECG unit is taking in the asynchronous ECG data and then making determinations about the presence/absence of a disease from this data (see U.S.C. 112b rejection above). Par. 0096 of Viktorovich teaches taking in the ECG data and then using unit [8] to make a prediction of a patient’s condition/disease and Par. 0526 of Hu disclose taking in synchronized and asynchronized data)
In regards to claim 6, the combined teachings of Viktorovich and Hu teach the system of claim 1, wherein: the diagnostic algorithm is trained with individual characteristic information of an examinee reflected therein; and the prediction unit predicts presence/absence of a disease and a degree of the disease from the asynchronous electrocardiogram data, measured by the single-lead electrocardiogram measurement unit, with the individual characteristic information reflected therein (Par. 0096 of Viktorovich teaches taking in the ECG data and then using unit [8] to make a prediction of a patients condition/disease based on previous readings of the patient, i.e. training from past readings).
In regards to claim 7, the combined teachings of Viktorovich and Hu teach the system of claim 6, wherein the individual characteristic information includes demographic information including gender and age of the examinee, basic health information including weight, height and obesity of the examinee, disease-related information including a past history, drug history and family history of the examinee, and test information regarding a blood test, genetic test, vital signs including blood pressure and oxygen saturation, and biosignals of the examinee (Par. 0111 of Viktorovich teaches using patients medical information about what and who is being studied ).
In regards to claim 8, the combined teachings of Viktorovich and Hu teach the system of claim 1, wherein the single-lead electrocardiogram measurement unit includes a wearable electrocardiogram patch, a smartwatch, or an electrocardiogram bar (Par. 0043 of Hu teaches using a smart watch to gather ECG data).
In regards to claim 9, the combined teachings of Viktorovich and Hu teach the system of claim 1, wherein: the prediction unit further includes a data conversion module configured to generate the asynchronous electrocardiogram data, measured from the single-lead electrocardiogram measurement unit, as numerical data through a specific formula; and the diagnostic algorithm uses numerical data corresponding to the asynchronous electrocardiogram data as input (Par. 0256 of Hu teaches making synchronized data asynchronized and vice versa. See above 112 rejections as well).
Conclusion
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/S.L.C./Examiner, Art Unit 3792
/NIKETA PATEL/Supervisory Patent Examiner, Art Unit 3792